PE20240807A1 - COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOL - Google Patents
COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOLInfo
- Publication number
- PE20240807A1 PE20240807A1 PE2024000057A PE2024000057A PE20240807A1 PE 20240807 A1 PE20240807 A1 PE 20240807A1 PE 2024000057 A PE2024000057 A PE 2024000057A PE 2024000057 A PE2024000057 A PE 2024000057A PE 20240807 A1 PE20240807 A1 PE 20240807A1
- Authority
- PE
- Peru
- Prior art keywords
- salts
- refers
- methods
- pharmaceutical composition
- aerosol
- Prior art date
Links
- 229940079593 drug Drugs 0.000 title abstract 2
- 239000003814 drug Substances 0.000 title abstract 2
- 238000000034 method Methods 0.000 title abstract 2
- 239000000443 aerosol Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- CDOOAUSHHFGWSA-OWOJBTEDSA-N (e)-1,3,3,3-tetrafluoroprop-1-ene Chemical compound F\C=C\C(F)(F)F CDOOAUSHHFGWSA-OWOJBTEDSA-N 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- 229940125390 short-acting beta agonist Drugs 0.000 abstract 2
- NRJAVPSFFCBXDT-HUESYALOSA-N 1,2-distearoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCCCC NRJAVPSFFCBXDT-HUESYALOSA-N 0.000 abstract 1
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 abstract 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 abstract 1
- 239000013543 active substance Substances 0.000 abstract 1
- 208000006673 asthma Diseases 0.000 abstract 1
- 229960004436 budesonide Drugs 0.000 abstract 1
- 229910001628 calcium chloride Inorganic materials 0.000 abstract 1
- 239000001110 calcium chloride Substances 0.000 abstract 1
- 239000003246 corticosteroid Substances 0.000 abstract 1
- 229960002848 formoterol Drugs 0.000 abstract 1
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229940071648 metered dose inhaler Drugs 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 150000003904 phospholipids Chemical class 0.000 abstract 1
- 239000003380 propellant Substances 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/16—Fluorine compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Refiere a una composicion farmaceutica administrable desde un inhalador de dosis medida, que comprende un propelente de grado farmaceutico (1E)-1,3,3,3-Tetrafluoro-1-propeno (HFO-1234ze(E)) con una pureza aproximada de 99,90%; uno o mas agentes activos seleccionados de un corticosteroide inhalado (ICS) como budesonida o sus sales, o un agonista beta de accion corta (SABA) como formoterol o sus sales; y particulas de fosfolipidos que comprenden microestructuras perforadas seleccionadas de 1,2-diestearoil-sn- glicero-3-fosfocolina (DSPC) y cloruro de calcio. Asimismo, refiere al uso de dicha composicion farmaceutica en la fabricacion de un medicamento para el tratamiento de asma o COPD, y metodos de tratamiento.Refers to a pharmaceutical composition administerable from a metered dose inhaler, comprising a pharmaceutical grade propellant (1E)-1,3,3,3-Tetrafluoro-1-propene (HFO-1234ze(E)) with an approximate purity of 99.90%; one or more active agents selected from an inhaled corticosteroid (ICS) such as budesonide or its salts, or a short-acting beta agonist (SABA) such as formoterol or its salts; and phospholipid particles comprising perforated microstructures selected from 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and calcium chloride. Likewise, it refers to the use of said pharmaceutical composition in the manufacture of a medication for the treatment of asthma or COPD, and treatment methods.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163220362P | 2021-07-09 | 2021-07-09 | |
| US202163282356P | 2021-11-23 | 2021-11-23 | |
| PCT/US2022/036543 WO2023283439A1 (en) | 2021-07-09 | 2022-07-08 | Compositions, methods and systems for aerosol drug delivery |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20240807A1 true PE20240807A1 (en) | 2024-04-18 |
Family
ID=82748203
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2024000057A PE20240807A1 (en) | 2021-07-09 | 2022-07-08 | COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOL |
| PE2024000056A PE20241067A1 (en) | 2021-07-09 | 2022-07-08 | COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOL |
| PE2024000058A PE20240808A1 (en) | 2021-07-09 | 2022-07-08 | COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOL |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2024000056A PE20241067A1 (en) | 2021-07-09 | 2022-07-08 | COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOL |
| PE2024000058A PE20240808A1 (en) | 2021-07-09 | 2022-07-08 | COMPOSITIONS, METHODS AND SYSTEMS FOR THE ADMINISTRATION OF DRUGS IN AEROSOL |
Country Status (28)
| Country | Link |
|---|---|
| US (5) | US20240358662A1 (en) |
| EP (6) | EP4197528B1 (en) |
| JP (3) | JP2024527348A (en) |
| KR (3) | KR20240042437A (en) |
| AU (3) | AU2022305962A1 (en) |
| CA (3) | CA3226557A1 (en) |
| CL (3) | CL2024000039A1 (en) |
| CO (3) | CO2024000631A2 (en) |
| CR (3) | CR20240063A (en) |
| DK (3) | DK4175620T3 (en) |
| DO (3) | DOP2024000004A (en) |
| EC (1) | ECSP24011022A (en) |
| ES (3) | ES2981709T3 (en) |
| FI (3) | FI4197528T3 (en) |
| HR (3) | HRP20240725T1 (en) |
| HU (3) | HUE067281T2 (en) |
| IL (3) | IL309908A (en) |
| LT (3) | LT4175619T (en) |
| MA (3) | MA60223B1 (en) |
| MX (3) | MX2024000467A (en) |
| PE (3) | PE20240807A1 (en) |
| PL (3) | PL4175620T3 (en) |
| PT (3) | PT4175620T (en) |
| RS (3) | RS65597B1 (en) |
| SI (3) | SI4175620T1 (en) |
| SM (3) | SMT202400312T1 (en) |
| TW (3) | TW202317079A (en) |
| WO (3) | WO2023283441A1 (en) |
Families Citing this family (8)
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|---|---|---|---|---|
| US20250345292A1 (en) * | 2022-04-28 | 2025-11-13 | Astrazeneca Ab | Combination of albuterol and budesonide for the treatment of asthma |
| CN116270464B (en) * | 2023-03-01 | 2025-09-30 | 深圳市贝美药业有限公司 | A kind of crisaborole aerosol and preparation method thereof |
| FR3150798B1 (en) | 2023-07-07 | 2025-11-21 | Aptar France Sas | Fluid product dispensing device |
| WO2025179179A1 (en) * | 2024-02-23 | 2025-08-28 | Astrazeneca Ab | Triple combination therapy for copd |
| WO2026006658A1 (en) * | 2024-06-27 | 2026-01-02 | Lupin Inc. | Stable pharmaceutical compositions for pressurized metered dose inhalers |
| WO2026011141A1 (en) * | 2024-07-05 | 2026-01-08 | Honeywell International Inc. | Compositions, devices and methods for respritory delivery of active pharmaceutical ingredients |
| US12496272B1 (en) | 2024-07-31 | 2025-12-16 | Amphastar Pharmaceuticals, Inc. | Stable epinephrine suspension formulation for inhalation with HFO propellant |
| US12383516B1 (en) | 2025-01-06 | 2025-08-12 | Amphastar Pharmaceuticals, Inc. | Albuterol aerosol suspension formulation for oral inhalation with high amount of green propellant hydrofluoroolefin (HFO) and free of co-solvent |
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